Claims Samsung's Biosimilar SB4 Infringed on Patents

Samsung Bioepis’ main office in Songdo, Incheon of Korea

Pfizer has filed a patent infringement lawsuit against Samsung Bioepis with the Australian Federal Court to suspend sales of the latter's SB4, a biosimilar of Enbrel, which is an autoimmune disease treatment sold by Pfizer.

This is the first time that Pfizer has filed a lawsuit against a Korean biotech company. In particular, the suit is very unusual, as Pfizer has filed it several years after the release of a biosimilar product. As such, attention is focused on Pfizer’s intention. Some analysts say that the global pharmaceutical giant wanted to keep Samsung Bioepis in check as Samsung Group started to nurture its pharmaceutical business in earnest by merging Samsung Biologics and Samsung Bioepis.

Pfizer holds the right to sell the autoimmune disease treatment Enbrel outside of North America. Enbrel was developed by U.S. pharmaceutical company Immunex. Amgen, a global pharmaceutical giant, acquired Immunex through an M&A deal and currently holds the original patent. Pfizer sells Enbrel worldwide under a licensing agreement with Amgen in all regions except North America. Enbrel’s core patents expired in 2012, but have been extended until 2028 in the US market alone.

Samsung Bioepis developed SB4, a biosimilar of Enbrel, in 2015 when Enbrel’s patent ended. Currently, it is sold as Benepali in Europe, as Etocobo in the United States and as Bransys in Australia. In 2021, SB4 sales amounted to US$561.6 million, accounting for 44.7 percent of Samsung Bioepis’ total sales (US$1255.1 million). SB4 surpassed Enbrel, the original drug, in Europe to log a market share of more than 40 percent. However, in the United States, Amgen filed a lawsuit immediately after SB4 received marketing approval from the U.S. Food and Drug Administration (FDA) in 2019. Samsung Bioepis lost the suit and SB4 cannot be sold in the U.S. until 2029.

Experts analyze Pfizer’s lawsuit as the global pharmaceutical giant’s strategic move to hold Samsung Bioepis in check. In general, pharmaceutical companies file litigation for the prohibition of sales or patent infringement at the time of patent expiration or approval to sell the biosimilars of their original drugs. However, Pfizer filed the suit more than six years after sales of SB4 started in Australia. It claimed that Samsung Bioepis infringed on the manufacturing process patents and demanded compensations for damage caused by SB4 sales.

This lawsuit is expected to expedite Samsung Biologics’ development of new drugs. “Samsung is expanding its CMO and CDMO business with the goal of becoming the world’s number one player,” said Lee Seung-gyu, vice chairman of the Korea Biotechnology Industry Organization. “However, there is a high possibility that the company will quickly shift its direction to new drug development as intellectual property (IP) disputes have recently expanded in the biosimilar market.”

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